This position is located onsite in our Raleigh, NC office.
POSITION OVERVIEW
Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; The Metasite and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration.
The Manager, Clinical Research is responsible for the operational oversight and daily management of Clinical Research Coordinators. As team manager, the individual has the discretion to make daily operational decisions, guided by an understanding of best practices, as well as convincingly recommending process improvements. The Manager, Clinical Research is responsible for overseeing the coordination of trial participation and study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Manager, Clinical Research is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to
- Assists in the interviewing of potential Clinical Research Coordinators (CRCs) candidates
- Oversees and builds Clinical Research Coordinator team
- Oversees the CRC new hire process to ensure that CRCs have completed the appropriate training
- Conducts in person CRC training for new CRC staff
- Mentors CRCs and guides them through studies, processes, issues, additional training needed, career advancement
- Supervises and assesses newly hired CRCs for core competencies and ability to perform the required duties of a CRC at Science 37
- Manages CRCs workload and work assignments
- Works with and advises Senior Leadership to identify the appropriate CRC for trial studies based on the individuals experience, knowledge, etc.
- Meets with the CRC team regularly and communicates performance expectations and guidelines
- Conducts performance reviews, calibration sessions, and feedback discussions with direct reports in a timely, frequent, and direct manner that is consistent with the company values
- Performs competency assessments across team and implements and monitors development plans with direct reports
- Promotes effective teamwork among CRCs and provides ongoing direction and management to develop skills for CRCs
- Responsible for ensuring CRCs complete accurate and timely data collection, documentation, entry, and reporting
- Assists Corporate Trainer with the development, oversight and delivery of project team training and training materials, as needed
- Oversees the CRC curriculum to make sure that annually it is up to date with most current CRC training needs and Science 37 processes. Recommend any changes to the above and implement upon approval.
- Assists with development and execution of CRC duties and work instructions, SOPs, Job Aids
- Identifies, recommends, and implements CRC process improvement initiatives
- Problem-solves varied solutions that require significant analysis or interpretation and investigative solutions
- Leads, presents and/or participates in internal and external meetings, as necessary
- Determines needed project processes; workflows; data needs for new studies and works with CRCs on implementation
- Completes periodic review of study specific processes to determine if modifications are needed to procedures to improve efficiency and quality
- Ensures research quality by practicing in compliance with SOPs, principles of GCP and applicable federal, state, and local regulations
- Ensures the completion of CRC tasks to determine that research is being conducted according to Science 37 and GCP guidelines
- Trains CRCs to provide a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards
QUALIFICATIONS & SKILLS
Qualifications
The following qualifications are preferred and/or equivalent applicable experience:
- Bachelor's degree preferred, or a combination of 2-year degree plus relevant work experience
- 2+ years of pharmaceutical-sponsored clinical research experience is preferred. DCT experience is a plus.
- Experience building, managing, and guiding individual(s) and/or a team is preferred
- Medical and scientific knowledge required
Skills/Competencies
- Strong communication and presentation skills - Excellent interpersonal skills and professional demeanor. Must have the ability to communicate accurately and clearly, both orally and in writing.
- Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Proficiency with MS PowerPoint required.
- Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
- Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities.
- Team management and collaborative capabilities - Commitment to collaboration, within and across departments. Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities.
- Interpersonal Savvy - Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach.
- Practices professionalism and integrity in all actions - Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
- Excellent problem-solving and people skills - Communicate ideas effectively to resolve conflicts and achieve business goals.
- Practices professionalism and integrity in all actions - Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
- Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through.
- Personnel management and team leadership skills- Demonstrated ability to train, coach and evaluate clinical trial team members. Strong focus on collaboration and ability to direct work.
- Extensive Knowledge of FDA regulations and GCP guidelines - Understands applicable regulations and implications for trial participation.
- Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities.
- Ability to motivate & influence - Ability to motivate, influence and guide team members and direct reports, gains commitments from others.
- Build & Manage Teams - Experience in building and guiding organizational teams. Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments.
- Ability to work independently, self-directed, strong work ethic and adherence to deadlines.
- Ability to be flexible and capable of working independently or as part of a team.
Capabilities
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written)
- Ability to cover nights and/or weekends as needed for oversight
REPORTING
Position reports to the Sr. Director, Clinical Research who will also assign projects, provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.
BENEFITS
At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work that adds to your professional development.
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply.